EMEA-002903-PIP01-20 - paediatric investigation plan

Anti-C1s Humanized IgG4 Monoclonal Antibody (BIVV020)

Key facts

• Active Substance:
  Anti-C1s Humanized IgG4 Monoclonal Antibody (BIVV020)
• Therapeutic area:
  • Haematology-Hemostaseology
  • Immunology-Rheumatology-Transplantation
  • Neurology
• Decision number:
  P/0087/2021
• PIP number:
  EMEA-002903-PIP01-20
• Pharmaceutical form(s):
  • Solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia purpura
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Genzyme Europe B.V.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2021

Decision

P/0087/2021 : EMA decision of 17 March 2021 on the granting of a product specific waiver for anti-C1s Humanized IgG4 Monoclonal Antibody (BIVV020) (EMEA-002903-PIP01-20)

AdoptedReference Number: EMA/97576/2021